Celgene's study data may boost cancer drug sales

JosephWalker

--Company to use study data to gain regulatory approval to market the drug for front-line patients

--Specific data points, such as length of progression-free survival, not disclosed

(Updates with details and analyst comment).

Celgene Corp.
CELG, -3.61%
said its flagship blood-cancer drug Revlimid helped extend the time that newly diagnosed multiple myeloma patients lived without their tumors growing larger in a late-stage study, which could help boost sales for the drug overseas and in the U.S.

The biopharmaceutical company said it would begin discussions with regulators as it applies for approval to market Revlimid as a front-line treatment. The drug is currently approved only for patients who have tried and failed at least one prior therapy.

Revlimid already is widely used with new patients in the U.S., where physicians have wide latitude to prescribe medication for unapproved, or off-label, use. International markets, however, can be much stricter, and analysts said new approvals in Europe and elsewhere could accelerate sales growth there.

Investors reacted positively to the news, and Celgene shares rose 7% to $133.86. However, Celgene did not disclose specific study data that will be of importance to regulators, such as the length of patients' progression-free and overall survival.

The company said the study met its primary endpoint of demonstrating a statistically significant extension in how long patients lived without their diseases getting worse, but that it would wait until an upcoming medical meeting to report specific survival and safety data, leading some analysts to express caution in over-interpreting the announcement.

"We find Celgene's announcement reassuring but frustratingly thin on details," said Geoffrey Porges, a Sanford C. Bernstein analyst. "Investors are unlikely to completely endorse the potential of frontline approval until they see the results."'

Revlimid sales rose 17.4% to $3.76 billion last year and represented more than two-thirds of Celgene's total revenue. Even as the drug has gained deeper market penetration, its overall growth also has begun to slow considerably, Baird analyst Christopher J. Raymond said. A more liberal use indication "could help reinvigorate the franchise," he said.

Celgene also markets Thalomid and Pomalyst for multiple myeloma, a cancer of the plasma cells. There are estimated to be more than 20,000 newly diagnosed multiple myeloma cases this year in the U.S., according to the American Cancer Society. Celgene's drugs compete against those made by Johnson & Johnson
JNJ, -0.72%
and Takeda Pharmaceutical Co. Ltd.(TKPYY 4502.TO), and Onyx Pharmaceuticals Inc.
ONXX

Celgene's study compared Revlimid in combination with the steroid drug dexamethasone versus a regimen of melphalan, prednisone and Celgene's Thalomid, known by the generic name thalidomide. The Revlimid combination demonstrated a statistically significant improvement in progression-free survival compared with the other arm.

Celgene shares have more than doubled in the past 12 months as its new product pipeline has matured and the company projected optimistic sales growth through 2017. The company in April saw first-quarter earnings fall 4.1% as higher expenses offset stronger revenue from Revlimid and Vidaza, another blood-cancer treatment.

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